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Title PYRAMAX(Pyronaridie-Artesunate) added to WHO's Model List of Essential Medicines (EML)
Date 2017.06.27 Hit 1457
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WHO’s Model Essential Medicines List (EML) is a globally accepted set of selected therapies

to help countries identify priority medicines to meet their health needs


In June 2017, pyronaridine-artesunate was added to the World Health Organization’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc) after a successful application to the EML was submitted by Shin Poong.


A fixed-dose combination of pyronaridine tetraphosphate and artesunate in tablets for the first-line treatment of both uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in adults and children ≥ 20kg, and child-friendly granules for children and infants weighing 5 kg to under 20 kg.


WHO’s Model EML1 identifies medicines that “satisfy the priority health care needs of the population.” In practical terms, the WHO Model EML can help countries consider revisions to their national EMLs, which in turn, inform the procurement decisions of central medical stores and the prioritization of medicines for use in-country.


With concerted global effort, malaria incidence and deaths fell dramatically between 2001 and 2015: it is estimated that of the 6.2 million lives saved from malaria over that period, 5.9 million (95%) were those of children under the age of 5 years. Despite this significant gain, in 2016 malaria took an estimated 429,000 lives, 306,000 of whom were young children. Inclusion of these new antimalarials into the EML will help make more child-friendly antimalarial treatments accessible to those who need them most and increase the number of high-quality ACT options for inclusion in national EMLs.

Pyramax, a fixed-dose combination of pyronaridine and artesunate co-developed by MMV and Shin Poong Pharmaceutical Co. Ltd., South Korea, is the newest ACT combination to be approved by a Stringent Regulatory Authority. It was the first and only ACT to be granted a positive scientific opinion under the European Medicines Agency’s (EMA) Article 58 procedure, and is the first and only ACT to be specifically indicated for the blood-stage treatment of both of the two main strains of malaria: P. falciparum and P. vivax. Pyramax is also the first Korean product included in WHO’s list of prequalified medicines for malaria


 

 

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